AX-2025-020706

MGF · 2 mg declared · Sangon Biotech (Shanghai) Co., Ltd. · lot SGN-2503-S9261

MARGINALPURITY ONLY

Report ID: AX-2025-020706
Compound: MGF
Compound class: Growth-hormone axis peptides
Supplier: SGN — Sangon Biotech (Shanghai) Co., Ltd.
Batch / lot: SGN-2503-S9261
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 24 May 2025
Submitted: 31 May 2025
Quarter: 2025-Q2
Submitter: m.vermeulen
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	99.48	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.52	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — truncated (1-20)	0.19	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.35	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.01	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.99	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.28	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.45	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	10.63	min	11.62 ± 0.30 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.02	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	43,284	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.15	—	no index criterion	REPORTED

Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

Figure 1. RP-HPLC trace, 30 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 43,284, and skew follows the reported asymmetry factor of 1.02. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.19 % impurity against a 99.48 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	MGF — main peak	10.63	4,835,036	99.48	—
2	truncated (1-20)	9.41	9,235	0.19	-486.271
3	acetyl adduct (+42 Da)	11.03	8,749	0.18	+42.011
4	aspartimide (−18 Da)	10.95	3,888	0.08	-18.011
5	deamidated (+1 Da)	10.39	3,402	0.07	+0.984
Closure check — purity + Σ impurities				100.00	CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

Figure	Supplier COA	This report	Index note
Purity (% area)	99.49	99.48	divergence +0.10 pp vs batch median
Total impurities (% area)	0.51	0.52
Largest single impurity (% area)	0.25	0.19
Water (%)	not stated	3.35
Counter-ion (%)	not stated	4.01
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.31	0.28
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 3 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 24 May 2025
Submitted to the index: 31 May 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 3

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

gradient_2531 May 2025

The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 30 min at Janoshik puts this comparison on a documented footing.

selection_bias31 May 2025

Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.

c18_2p631 May 2025

Pore size matters on the larger analogues. A 100 Å pore excludes part of a 4 kDa peptide from the internal surface and shifts it early relative to a 300 Å column.

Section 7

Related records

Same batch — lot SGN-2503-S9261 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020704	SGN-2503-S9261	PeptideMeter	2025-Q2	99.39	3.50	104.6	Buyer-sourced	0	PASS
AX-2025-020705	SGN-2503-S9261	PeptideMeter	2025-Q2	99.35	3.18	92.6	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent MGF records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043660	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.30	4.25	95.8	Buyer-sourced	PASS
AX-2026-043656	PPG	PPG-2512-G7713	PeptideMeter	2026-Q2	99.09	4.22	99.3	Buyer-sourced	PASS
AX-2026-043657	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.06	4.25	107.0	Buyer-sourced	PASS
AX-2026-043466	BCH	BCH-2511-D5168	Janoshik	2026-Q2	99.04	5.33	103.5	Buyer-sourced	PASS
AX-2026-043464	BCH	BCH-2511-D5168	VendorInvestigate	2026-Q2	99.39	5.79	100.2	Buyer-sourced	PASS
AX-2026-043655	PPG	PPG-2512-G7713	Medutest	2026-Q2	99.03	4.14	99.6	Buyer-sourced	PASS
AX-2026-043467	BCH	BCH-2511-D5168	Janoshik	2026-Q2	99.46	5.95	—	Supplier-supplied	PASS
AX-2026-043652	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.33	3.87	101.6	Buyer-sourced	PASS

Other recent SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS